Valsartan and amlodipine tablets
[PDF File]HIGHLIGHTS OF PRESCRIBING INFORMATION AMLODIPINE, VALSARTAN AND ...
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• Amlodipine, valsartan and hydrochlorothiazide tablets USP, 5 mg/160 mg/25 mg are yellow colored, capsule shaped, film coated, biconvex tablets, debossed with ‘LU’ on one side and ‘W42’ on the other side. • Amlodipine, valsartan and hydrochlorothiazide tablets USP, 10 mg/160 mg/25 mg are beige
[PDF File]Exforge, INN: amlodipine / valsartan - European Medicines Agency
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Exforge is a fixed combination containing two active substances: amlodipine (as the besilate salt) and valsartan and is presented as film-coated tablets. The tablets contain 5/80 mg, 5/160 mg or 10/160 mg of amlodipine and valsartan respectively. It is packaged in PVC/PVDC blister packs or PA/AL/PVC blister packs. Active Substance
[PDF File]µ Amlodipine and Valsartan Tablets - USP–NF
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Official November 1, 2017 Amlodipine 1. Column: 3.9-mm × 15-cm; 5-µm packing L1 Amlodipine and Valsartan Tablets Temperatures Autosampler: 10° Column: 30° DEFINITION Flow rate: 1.0 mL/min Amlodipine and Valsartan Tablets contain NLT 90.0% and Injection volume: 10µL NMT 110.0% of the labeled amount of amlodipine System suitability (C 20H ...
[PDF File]Amlodipine, Valsartan and Hydrochlorothiazide Tablets Type of Posting ...
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The typical retention time for amlodipine is about 2.8 min. Minor editorial changes have been made to update the monograph to the current USP style. The Amlodipine, Valsartan and Hydrochlorothiazide Tablets Revision Bulletin supersede the currently official Amlodipine, Valsartan and Hydrochlorothiazide Tablets monograph.
Mylan Pharmaceuticals Inc. AMLODIPINE AND VALSARTAN ... - DailyMed
amlodipine and valsartan tablets-treated patients and 2.1% in the placebo-treated group. The most common reasons for discontinuation of therapy with amlodipine and valsartan tablets were peripheral edema and vertigo. The adverse experiences that occurred in clinical trials (≥ 2% of patients) at a higher ...
[PDF File]Imprida, INN-Amlodipine besylate/valsartan - European Medicines Agency
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Imprida is a fixed combination containing two active substances: amlodipine (as the besilate salt) and valsartan and is presented as film-coated tablets. The tablets contain 5/80 mg, 5/160 mg or 10/160 mg of amlodipine and valsartan respectively. It is packaged in PVC/PVDC blister packs or PA/AL/PVC blister packs. Active Substance
[PDF File]SDS - Amlodilpne ans Valsartan Tablets - March 2017 - Lupin
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Amlodipine and Valsartan Tablets USP 5/160 mg, 10/160 mg, 5/320 mg and 10/320 mg Manufacturer Lupin Limited Goa 403 722 India Distributor Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Harborplace Tower, 21st Floor, Baltimore, Maryland 21202 United States Tel. 001-410-576-2000 Fax. 001-410-576-2221 Section 2: Hazard(s) Identification
[PDF File]Amlodipine, Valsartan, and Hydrochlorothiazide Tablets, 5 mg/160 mg/12. ...
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The Division of Bioequivalence has determined your Amlodipine, Valsartan, and Hydrochlorothiazide Tablets, 5 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/12.5 mg, 10 mg/160 mg/ 25 mg, and 10 mg/320 mg/25 mg, to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Exforge HCT of Novartis
[PDF File]. Amlodipine, Valsartan, and Hydrochlorothiazide Tablets
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DEFINITION Valsartan/ Concentra- Nominal tion Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Hydrochlo- tion Concentra- of Hydro-contain NLT 92.5% and NMT 107.5% each of the la-rothiazide of tion chlorothia-beled amounts of amlodipine (C (mg/mg/ Amlodipine of Valsartan zide 20H 25ClN 2O 5), valsartan (C mg) (mg/mL) (mg/mL) (mg/mL) 24H ...
[PDF File]FDA-APPROVED PATIENT LABELING PATIENT INFORMATION and Valsartan (val ...
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How should I store amlodipine and valsartan tablets? • Store at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF). • Keep amlodipine and valsartan tablets dry (protect it from moisture). Keep amlodipine and valsartan tablets and all medicines out of the reach of children. General Information about amlodipine and valsartan tablets
AMLODIPINE AND VALSARTAN- amlodipine and valsartan tablet
When pregnancy is detected, discontinue Amlodipine and Valsartan Tablets as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) INDICATIONS AND USAGE Amlodipine and Valsartan Tablets are the combination tablets of amlodipine, a dihydropyridine calcium channel ...
[PDF File]Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) Label
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5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets – White, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VCL” on the other side. 10 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets – Pale yellow, non-scored,
[PDF File]Page 1 of 34 - Lupin
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Page 2 of 34 FULL PRESCRIBING INFORMATION WARNING: FETAL TOXICITY When pregnancy is detected, discontinue amlodipine and valsartan tablets as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) 1 INDICATIONS AND USAGE 1.1 Hypertension
Lupin Pharmaceuticals, Inc. AMLODIPINE AND VALSARTAN - DailyMed
Tablets (amlodipine/valsartan mg): 5/160, 10/160, 5/320, 10/320 (3) CONTRAINDICATIONS Known hypersensitivity to any component; Do not coadminister aliskiren with amlodipine and valsartan in patients with diabetes (4) WARNINGS AND PRECAUTIONS Hypotension: Correct volume depletion prior to initiation (5.2)
[PDF File]ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - European Medicines Agency
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The recommended dose of Amlodipine/Valsartan Mylan is one tablet per day. Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets Amlodipine/Valsartan Mylan 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
[PDF File]Draft Guidance on Amlodipine Besylate; Valsartan - Food and Drug ...
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Amlodipine and valsartan in plasma. Bioequivalence based on (90% CI): Amlodipine and valsartan . Waiver request of in-vivo testing: 5 mg (base);160 mg and 5 mg (base);320 mg based on (i) acceptable bioequivalence studies on the 10 mg (base);160 mg and 10 mg (base);320 mg strengths, (ii) acceptable
Lupin Pharmaceuticals, Inc. AMLODIPINE AND VALSARTAN - amlodipine and ...
Tablets (amlodipine/valsartan mg): 5/160, 10/160, 5/320, 10/320 (3) CONTRAINDICATIONS Known hypersensitivity to any component; Do not coadminister aliskiren with amlodipine and valsartan in patients with diabetes (4) WARNINGS AND PRECAUTIONS Hypotension: Correct volume depletion prior to initiation (5.2)
[PDF File]Amlodipine/Valsartan Mylan, INN-amlodipine/valsartan
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Amlodipine/Valsartan Mylan 5 mg/80 mg, 5 mg/160 mgand 10 mg/160 mg, film -coated tablets is a generic version of the already approved reference product Exforge 5 mg/80 mg, 5 mg/160 mg and 10 mg/160mg film-coated tablets by Novartis Europharm Limited, which has been marketed i n the UE for more than 6 years.
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